Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil

Universidade Federal de Goias

Status: Completed

Conditions: Anemia

Treatments: Drug: ferrous sulfate; Drug: placebo (folic acid); Drug: folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00701246

FANUT 302004

Details and patient eligibility

About

Iron deficiency anemia is the most common nutritional problem in the world.

The objectives of this study are:

• to evaluate the prevalence of anemia in children from 6 to 24 months of age and the therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin levels.
• to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic

Study hypothesis:

• The ferrous sulfate plus folic acid can improve the response on hemoglobin levels.
• The folic acid supplementation with ferrous sulfate have effect on the linear and weight growth of anemic and non-anemic.

Full description

Purpose

The objective of this study were:

• to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid.
• to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic.

A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goias State, Brazil. The children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50μg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50μg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. Supplementation lasted approximately three months.

Enrollment: 196 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• from 6 to 24 months
• born at term
• non-twins
• with parental approval for participation in the study
• attending municipal daycare centers with mor than four children each

Exclusion criteria

• Children with special needs
• low birth weight (<2.500g)
• with growth-impairing heart diseases
• neurological syndromes
• sickle-cell anemia
• sickle-cell trait
• under treatment for anemia at the time of the first interview or screening performed by the pediatrician
• those no longer attending the daycare center
• the clinical trial excluded children with hemoglobin >=7 amd <=8g/dL.
• For the second objective: incomplete anthropometric surveys

Trial design

196 participants in 4 patient groups, including a placebo group

I

Experimental group

Description:

I Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg)

Treatment:

Drug: folic acid

Drug: ferrous sulfate

II

Placebo Comparator group

Description:

II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo.

Treatment:

Drug: ferrous sulfate

Drug: placebo (folic acid)

III

Experimental group

Description:

Prevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid

Treatment:

Drug: folic acid

Drug: ferrous sulfate

IV

Placebo Comparator group

Description:

1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week.

Treatment:

Drug: ferrous sulfate

Drug: placebo (folic acid)